TerminatedPhase 2

ELB139 Given Orally to Patients With Concurrent Panic Disorder, Challenged by CO2 Inhalation After a Single Dose and One Week of Treatment

Germany, Netherlands24 participantsStarted 2006-05

Plain-language summary

This study is designed to investigate if 600 mg ELB139 given orally t.i.d. to patients suffering from panic disorder is effective in reducing anxiety evoked by inhalation of 35% CO2 measured by a visual analogue scale after the first intake and after approximately one week of treatment as compared to placebo treatment.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of concurrent panic disorder * At least 2 panic attacks within the 4 weeks before the screening visit * Naïve to the CO2 challenge test * Age 18-65 years (inclusive) * Ability to comply with all procedures mandated by the study protocol * Negative pregnancy test and adequate contraceptive measures Exclusion Criteria: * History of poly-pharmacotherapy for panic disorder or treatment resistance * Any current psychiatric Axis I DSM-IV diagnosis other than panic disorder, except concurrent simple phobia * History of abuse of benzodiazepines or tolerance to effects of benzodiazepine * Any concomitant psychotropic medication * Evidence of impaired hepatic, renal or cardiac functions * Participation in any drug trial in the preceding 6 months

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

degree of subjective anxiety as measured on a Visual Analogue Scale for Anxiety(VAS-A) assessed immediately after the CO2-challenge (VAS-A-post)

difference of the degree of anxiety measured as the difference between the pre- and post challenge scores on the Visual Analogue Scale for Anxiety (VAS-A-delta)

Trial details

NCT IDNCT00322803

Sponsorelbion AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Panic Disorder trials